A ranar 11 ga Yuni, Kelun-Biotech ta sanar da cewa Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta kasar Sin ta ba ta izinin yin maganin cutar kansar huhu ta farko (NSCLC) da ta bulla a yankin ko kuma ta kamu da cutar kansar huhu ba tare da wani kwayar halitta ba, tare da hadin gwiwar PD-L1 monoclonal antibody tagitanlimab (科泰莱).
Sac-TMT, wani muhimmin samfurin Kamfanin, wani sabon nau'in TROP2 ADC ne na ɗan adam wanda Kamfanin ke da haƙƙin mallakar fasaha, wanda ke nufin ciwace-ciwacen da suka ci gaba kamar NSCLC, ciwon nono (BC), ciwon ciki (GC), ciwon mata, da sauransu. An haɓaka Sac-TMT tare da sabon mahaɗi don haɗa nauyin da ake buƙata, wani mai hana topoisomerase I na belotecan tare da rabon magani zuwa ga antibody (DAR) na 7.4. Sac-TMT musamman yana gane TROP2 a saman ƙwayoyin ciwon ta hanyar ƙwayoyin rigakafi na monoclonal masu sake haɗawa, wanda ƙwayoyin ciwon ke haifarwa kuma yana fitar da KL610023 a cikin ƙwayoyin halitta. KL610023, a matsayin mai hana topoisomerase I, yana haifar da lalacewar DNA ga ƙwayoyin ciwon, wanda hakan ke haifar da kamawa da kuma apoptosis. Bugu da ƙari, yana kuma fitar da KL610023 a cikin yanayin ƙwayar ciwon. Ganin cewa KL610023 yana iya shiga cikin membrane, yana iya ba da damar tasirin gani, ko kuma a wata ma'anar yana kashe ƙwayoyin ƙari da ke kusa.
Wannan Tsarin Maganin Ci Gaba ya dogara ne akan inganci da bayanan aminci daga ƙungiyar marasa ƙarfi na binciken Phase II OptiTROP-Lung01.
Sakamakon binciken OptiTROP-Lung01 Phase II, wanda aka yi a kan sac-TMT tare da KL-A167 (wani maganin rigakafi na monoclonal anti-PD-L1) a matsayin magani na farko ga marasa lafiya da suka kamu da cutar NSCLC ta hanyar direba da kuma waɗanda ba su da kwayar halitta, an gabatar da su a taron shekara-shekara na CSCO na 2024.
Binciken ya nuna cewa: Ga Cohort 1A, matsakaicin binciken ya kasance watanni 14.0, tare da ƙimar amsawar gaske (ORR) na 48.6% (18/37, shari'o'i 2 suna jiran tabbatarwa), ƙimar sarrafa cututtuka (DCR) na 94.6%, matsakaicin rayuwa ba tare da ci gaba ba (PFS) na watanni 15.4 (95% CI: 6.7, NE), da ƙimar PFS na watanni 6 na 69.2%; ga Cohort 1B, matsakaicin binciken ya kasance watanni 6.9, tare da ORR na 77.6% (45/58, shari'o'i 5 suna jiran tabbatarwa), DCR na 100.0%, matsakaicin PFS da ba a kai ga cimma ba tukuna, da ƙimar PFS na watanni 6 na 84.6%.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Yuni-12-2025